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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003632-68 | EudraCT Number |
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The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.
The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH001 dose A | Experimental |
| |
| GH001 dose B | Experimental |
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| GH001 dose C | Experimental |
| |
| GH001 dose D | Experimental |
| |
| GH001 Individualized Dosing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 Methoxy N,N Dimethyltryptamine | Drug | GH001 administered via inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of GH001 | The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses. | up to 7 days |
| The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | Visual Analogue Scale scored from 0-100 | Retrospectively assessed at 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GH Research Clinical Team | GH Research Ireland Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34912222 | Result | Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021. |
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| ID | Term |
|---|---|
| D008732 | Methoxydimethyltryptamines |
| ID | Term |
|---|---|
| D004130 | N,N-Dimethyltryptamine |
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
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Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
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|
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D002027 | Bufotenin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012701 | Serotonin |